Evidence map›Paper›PMID 36380284›Full record

Trial reportThe journal of headache and pain2022

Erenumab versus topiramate: post hoc efficacy analysis from the HER-MES study.

Marc Ehrlich, Christian Hentschke, Christian Sieder, Monika Maier-Peuschel, Uwe Reuter

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of headache and pain, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03828539 (Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.7field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03828539 phase4completednot on this map

Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting

TypeinterventionalSponsorNovartis PharmaceuticalsRan2019 to 2020Enrolled777ConditionsMigraineArmsErenumab, Topiramate, Erenumab matching placebo, Topiramate matching placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Marc EhrlichNovartis Pharma GmbH, Nuremberg, Germany.
Christian HentschkeNovartis Pharma GmbH, Nuremberg, Germany.
Christian SiederNovartis Pharma GmbH, Nuremberg, Germany.
Monika Maier-PeuschelNovartis Pharma GmbH, Nuremberg, Germany.
Uwe ReuterDepartment of Neurology, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. uwe.reuter@charite.de.
Novartis (Germany) · DECharité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveHER-MES was the first head-to-head, phase 4 trial to assess the tolerability and effectiveness of erenumab against standard of care treatment (topiramate). This post hoc analysis compared the efficacy of erenumab with topiramate in patients who completed the trial on study medication.

methodsPost hoc sensitivity analysis was performed using the full analysis set. Outcomes assessed included the proportion of patients with a ≥50% reduction in monthly migraine days (MMD) from baseline (50% responder rate), over the last 3 months (months 4, 5, and 6) of the double-blind treatment phase (DBTP), the 50% responder rate during the first month of the DBTP, and change from baseline in MMD during the DBTP. Multiple imputation was done for efficacy values of patients who discontinued study treatment.

resultsPatients (N = 777) were randomly assigned (1:1) to either 70 or 140 mg/month erenumab (N = 389) or 50-100 mg/day topiramate (N = 388). Of these, 334 patients (85.9%) receiving erenumab, and 231 patients (59.5%) receiving topiramate completed the DBTP on study medication. Patients on study medication until the end of the DBTP received a mean dose of 119 mg/month for erenumab and 92 mg/day for topiramate. At month 1, a significantly greater proportion of patients receiving erenumab (39.2%) reported ≥50% reduction in MMD from baseline compared with those receiving topiramate (24.0%; p < 0.001). In the last 3 months, a significantly larger proportion of patients receiving erenumab (60.3%) achieved ≥50% reduction in MMD from baseline compared with those receiving topiramate (43.3%; p < 0.001). Patients receiving erenumab demonstrated significantly greater reductions in MMD during the last 3 months from baseline versus those receiving topiramate (- 6.13 vs - 4.90; 95% CI: - 1.87 to - 0.61; p < 0.001).

conclusionsThis post hoc analysis demonstrated significantly superior efficacy of erenumab versus topiramate in achieving a ≥50% reduction in MMD with an early onset of efficacy.

trial registrationClinicalTrials.gov NCT03828539 .

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersDouble-Blind MethodHumansTopiramateTreatment OutcomeAntibodies, Monoclonal, HumanizederenumabTopiramateCalcitonin gene-related peptideEfficacyErenumabMigrainePreventiveStandard of careTopiramate

Identifiers

PMID36380284
PMCPMC9664641
OpenAlexW4309223501

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.